The Genomic Approach

A genomic test measures expression or sequence of genes within a sample of tumor tissue. The Oncotype DX Genomic Prostate Score (GPS) assay uses genomics to help predict the aggressiveness of prostate tumors.

The Oncotype DX GPS assay is the only genomic test that was designed specifically for use in men with clinically low- or favorable intermediate-risk cancer who are deciding between active surveillance and treatment. This genomic test:

The only genomic assay designed to help make treatment decisions at the time of diagnosis
  • Has been validated in multiple contemporary and clinically-relevant patient populations.1-3
  • Requires a very small sample of tumor from a single-needle biopsy core.1,2
  • Assess expression of genes that are reliably recovered and predictive of clinically relevant outcomes across multiple tumor foci.1,2
  • Provides information that is distinct from other clinical parameters like prostate-specific antigen (PSA) level and Gleason score.1-3
  • Refines risk based on estimation of likelihood of aggressive disease, and 10-year risk of metastasis and mortality after radical prostatectomy.1-3
  • Is included in National Comprehensive Cancer Network® (NCCN) guidelines and American Society of Clinical Oncology® (ASCO) guidelines as an option for patients with clinically low- or favorable intermediate-risk prostate cancer.4,5

Genomic testing vs. Genetic testing

Genetic tests typically screen for inherited risk factors and identify changes in chromosomes and genes—which can help in understanding patient risk for having cancer or other diseases.

Genomic tests examine the activity and sequence of genes within a sample of tumor tissue to provide unique information about tumor biology that other clinical pathological factors simply cannot. The activity and interaction of genes influences the behavior of a tumor, including its aggressiveness and how likely it is to grow and spread.

Confidently recommend a course of care

Although biopsies provide important information, they sample very small areas of the prostate and do not always convey an accurate assessment of the aggressiveness and the extent of the cancer. Prostate biopsy findings often incorrectly represent true prostate pathology; the actual pathology can be more or less aggressive than what is visible in the biopsy sample.6 The Oncotype DX GPS assay is designed to provide precise and predictive information you need to more confidently assess risk and guide treatment decisions for your clinically low- and favorable intermediate-risk prostate cancer patients.

The Oncotype DX GPS test provides insight into how aggressive a tumor might be, which is essential in management planning, when you consider:

  • Prostate cancer accounts for over 26,000 cancer related deaths every year.7
  • Biopsy findings can misrepresent the true tumor pathology and miss high-risk cancer.8
  • Not all prostate cancers need immediate treatment—many men with low- or favorable intermediate-risk disease can be successfully and safely managed with active surveillance.9

  1. Klein et al. Eur Urol. 2014.
  2. Cullen et al. Eur Urol. 2015.
  3. Van den Eeden et al. J Urol. 2017.
  4. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer V2.2018. © National Comprehensive Cancer Network, Inc. 2018. Accessed February 20, 2018. To view the most recent and complete version of the guideline, go online to NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
  5. ASCO: Eggener et al. J Clin. Oncol. Published online December 12, 2019.
  6. Gearman et al. J Urol. 2017.
  7. Siegel at al. Ca Cancer J Clin. 2016.
  8. Hamdy et al. N Engl J Med 2016.
  9. Yamamoto et al. J Urol 2016.
National Comprehensive Cancer Network (NCCN) and NCCN are registered trademarks of NCCN. NCCN does not endorse any product or therapy.

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